Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 079183
Company: HOSPIRA INC

Products on ANDA 079183

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 079183

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/15/2010	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/079183s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/03/2019	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
10/03/2019	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
11/17/2016	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
11/17/2016	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 079183

GEMCITABINE HYDROCHLORIDE

INJECTABLE;INJECTION; EQ 2GM BASE/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	202997	DR REDDYS LABS LTD
GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	090242	FRESENIUS KABI USA
GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	090799	FRESENIUS KABI USA
GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	079183	HOSPIRA INC